Self-aggregating protein compositions and use as sealants

Abstract

There is described a bio-compatible aqueous slurry for forming a fluid-tight barrier on a surface of a porous implantable article. This aqueous slurry includes a self-aggregating protein comminutate having a substantially uniform particle size, a bio-compatible plasticizer and water. This aqueous slurry is further characterized by having a viscosity of about 8,000 centipoise to about 60,000 centipoise at 25° C. and a pH sufficient to maintain the protein suspended in the slurry.

1. An implantable member for use in the body comprising:
 a porous biocompatible substrate; and 
 an aqueous non-crosslinked sealant composition in intimate contact with said porous substrate for forming a substantially fluid-tight seal, wherein said sealant composition forms said substantially fluid-tight seal in absence of cross-linking, said sealant composition comprising:
 a self-aggregating protein comminutate composition comprising particles of substantially the same diameter and water;
 wherein said protein composition has a pH sufficient to maintain said protein comminutate in particulate form. 
 
 
 
     
     
       2. The implantable member of  claim 1 , wherein said sealant composition further comprises a plasticizer. 
     
     
       3. The implantable member of  claim 1 , wherein said sealant composition is in a dry state on said substrate. 
     
     
       4. The implantable member of  claim 1 , wherein said sealant composition further comprises a platicizer. 
     
     
       5. The implantable member of  claim 1 , wherein said self-aggregating protein is present in said sealant composition at concentrations of from about 1% to about 3% by weight. 
     
     
       6. The implantable member of  claim 1 , wherein said self-aggregating protein is selected from the group consisting of collagen, fibronectin, vitronectin, proteoglycan, laminin, hyaluronic acid, tenascin, integrin, cadherin and mixtures thereof. 
     
     
       7. The implantable member of  claim 6 , wherein said self-aggregating protein is type I bovine collagen. 
     
     
       8. The implantable member of  claim 1 , wherein said sealant composition further comprises a permeability lowering composition. 
     
     
       9. The implantable member of  claim 8 , wherein said permeability lower composition comprises from about 0% to about 24% ethanol. 
     
     
       10. The implantable member of  claim 4 , wherein said plasticizer is one of glycerol and sorbitol. 
     
     
       11. The implantable member of  claim 4 , wherein said plasticizer is present in said sealant composition at about 8% to about 30% by weight. 
     
     
       12. The implantable member of  claim 1 , wherein said sealant composition further comprises a bio-active agent. 
     
     
       13. The implantable member of  claim 10 , wherein said bio-active agent is selected from the group consisting of antibiotics, anticoagulants, antibacterial agents and mixtures thereof. 
     
     
       14. The implantable member of  claim 1 , wherein said sealant composition has a viscosity of about 30,000 centipose to about 50,000 centipoise. 
     
     
       15. The implantable member of  claim 1 , wherein said pH is in a range sufficiently outside the isoelectric point of said protein comminutate to maintain said protein in an aqueous state. 
     
     
       16. The implantable member of  claim 1 , wherein said pH is from about 3.5 to about 3.9. 
     
     
       17. The implantable member of  claim 1 , wherein said sealant composition has a viscosity of about 8,000 centipoise to about 60,000 centipoise at 25° C.